Polyphor and EnBiotix to Merge, Plan Trials in 2 Lung Infection Therapies

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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CF inhalation therapy trials | Cystic Fibrosis News | companies plan merger

EnBiotix has purchased murepavadin, an investigational inhaled antibiotic to treat Pseudomonas aeruginosa infections in people with cystic fibrosis (CF), from Polyphor.

The two companies also entered into an agreement to merge, wherein Polyphor will acquire all EnBiotix stock in exchange for Polyphor stock newly issued upon closing. The merger is expected to close by year’s end, assuming the agreement is approved by both companies’ shareholders, as well as assessment of tax consequences and other conditions.

Once established, the newly combined company plans to open clinical trials into its candidates for CF lung infections: one in murepavadin, and the other in ColiFin (inhaled colistimethate sodium), which is approved in Europe.

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“After an extensive and thorough review of a full range of strategic options for Polyphor, we are very pleased to announce the signing of a merger agreement with EnBiotix,” Kuno Sommer, chairman of the board of directors at Polyphor, said in a press release.

“We believe the merged company’s strong pipeline and focus on rare diseases and oncology can provide substantial opportunities to benefit patients, in particular cystic fibrosis patients with two clinical stage programs,” Sommer added.

EnBiotix’s acquisition of murepavadin is expected to finish this month, before the companies’ merger. EnBiotix has the option to reverse the sale if Polyphor were to cancel the merger agreement.

The merged company, which will have a new name (not yet disclosed), is planning to initiate Phase 1 clinical testing of murepavadin in CF.

Murepavadin is a new type of antibiotic that works by disrupting the outer membrane of bacteria. In preclinical experiments, it showed a potential to kill P. aeruginosa, a common cause of serious lung infections in people with CF, and specificity against multi-drug resistant strains. Polyphor received an award of up to $3.3 million to aid the clinical development of murepavadin from the Cystic Fibrosis Foundation last year.

In addition, the merged company plans to launch a Phase 3 clinical trial of ColiFin, a nebulized therapy that has been approved to treat CF lung infections in Europe for over a decade. EnBiotix owns the license for ColiFin outside of Europe, through an agreement with PARI Pharma.

Upon completion of the Phase 3 trial, the merged company plans to seek approval of ColiFin in the U.S.

“We believe the merged company will provide a powerful platform for pipeline and corporate development, and look forward to pursuing additional partnering opportunities as we seek to address the unmet needs of our target patient populations,” said Jeffrey D. Wager, MD, chairman and CEO of EnBiotix.